The Federal Office for Safety in Health Care has been informed by the Danish authority that it has been informed by the Danish Born Donor Bank (DK261306) that an offspring of the sperm donor Peters was born with a congenital structural heart defect (muscular ventricular septal defect and atrial septal defect). The donor/gametes were permanently blocked.

The Federal Office for Safety in Health Care has been informed by the Danish authority that it has been informed by the Danish tissue bank European Sperm Bank (DK257572) that the sperm donor 8324/Iners is a carrier of carnitine palmitoyltransferase 2 (CPT2) deficiency due to a mutation in the CPT2 gene. The donor/the donor gametes were permanently blocked.

This issue of RMS NEWS again contains current and relevant news for our applicants for marketing authorisations with Austria as RMS.

Recall due to unregistered serial numbers

Recall due to increased release of active ingredient

All ongoing clinical trials need to be converted to Clinical Trials Information System ("CTIS") in accordance with Regulation (EU) 536/2014 ("CTR") by January 31, 2025. This date marks the end of a three-year transition period that began when the CTR came into force in the EU. Clinical trials that are not converted by the sponsor in time lose their legal basis and will have to be terminated by the National authority.

The Federal Office for Safety in Health Care has been informed by the Danish authority that it has been informed by the Danish tissue bank European Sperm Bank (DK257572) that the sperm donor 28257/Florens is a carrier of the autosomal recessive disease spinal muscular atrophy (SMA). The donor/gametes were permanently blocked.

The pilot phase for the new medicines information system of the Federal Office for Safety in Health Care (BASG) begins on 21 January 2025.

Up-to-date information from the 09.12.-12.12.2024 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.

If a manufacturer expects that there will be interruptions in the supply of a medical device, it must report this to the competent authority in accordance with Article 10a of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). You can find more information here: https://www.basg.gv.at/fuer-unternehmen/medizinprodukte/hersteller#c24702